Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis (MAGiC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01197417
Recruitment Status : Completed
First Posted : September 9, 2010
Results First Posted : September 7, 2015
Last Update Posted : January 27, 2016
Sponsor:
Collaborator:
Pediatric Emergency Care Applied Research Network
Information provided by (Responsible Party):
Medical College of Wisconsin

Tracking Information
First Submitted Date  ICMJE August 31, 2010
First Posted Date  ICMJE September 9, 2010
Results First Submitted Date  ICMJE August 5, 2015
Results First Posted Date  ICMJE September 7, 2015
Last Update Posted Date January 27, 2016
Study Start Date  ICMJE December 2010
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2010)
Hospital Length of Stay (Hours) [ Time Frame: From the time of the start of first study med infusion until hospital discharge or 12 hours after the last IV opioid, whichever occurs first, up to 10 days post enrollment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01197417 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2015)
  • Number of Morphine Equivalents Per Kilogram of Body Weight Used During Hospitalization [ Time Frame: Total morphine equivalents used during the hospitalization will be recorded on the day of discharge, up to 10 days post enrollment ]
  • Hypotension Associated With Infusion [ Time Frame: Blood pressure will be monitored every 8 hours, concurrent with each infusion, and for 20-30 minutes after infusion completion, until discharge, up to 2 days post enrollment ]
    For each study drug infusion, systolic blood pressure (SBP) was measured just prior to the start of the infusion and again every 10 minutes until 30 minutes until the end of the infusion. Hypotension was defined as a greater than 20% reduction in SBP relative to corresponding baseline measurement for any study drug infusion.
  • Warm Sensation Associated With Study Drug Infusion [ Time Frame: Patient-reported warm sensation upon infusion will be monitored every 8 hours, concurrent with each infusion, and for 20-30 minutes after infusion completion, until discharge, up to 2 days post enrollment ]
    Patient spontaneously reported feelings of warmth during any study drug infusion.
  • Rehospitalization [ Time Frame: Rehospitalization will be measured at 7 days post discharge and at the follow-up visit (on average, 30 days post discharge) ]
  • Development of Acute Chest Syndrome (ACS) [ Time Frame: Patients will be monitored daily, on average, during their length of stay until discharge, up to 10 days post enrollment ]
  • Hospital Length of Stay [ Time Frame: Start of first study drug infusion to actual hospital discharge ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2010)
  • Number of Morphine Equivalents Per Kilogram of Body Weight Used During Hospitalization [ Time Frame: Total morphine equivalents used during the hospitalization will be recorded on the day of discharge, up to 10 days post enrollment ]
  • Hypotension Associated With Infusion [ Time Frame: Blood pressure will be monitored every 8 hours, concurrent with each infusion, and for 20-30 minutes after infusion completion, until discharge, up to 2 days post enrollment ]
    Defined as >20% SBP reduction from measurement in the outpatient clinic within the last year while well, when available, or from the median normal blood pressure for age and height
  • Warm Sensation Associated With Study Drug Infusion [ Time Frame: Patient-reported warm sensation upon infusion will be monitored every 8 hours, concurrent with each infusion, and for 20-30 minutes after infusion completion, until discharge, up to 2 days post enrollment ]
  • Rehospitalization [ Time Frame: Rehospitalization will be measured at 7 days post discharge and at the 1 month follow-up visit (on average, 30 days post discharge) ]
  • Development of Acute Chest Syndrome (ACS) [ Time Frame: Patients will be monitored daily, on average, during their length of stay until discharge, up to 10 days post enrollment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis
Official Title  ICMJE Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis
Brief Summary The purpose of this study is to determine the safety and efficacy of intravenous magnesium in shortening the duration of a pain crisis and to determine the health-related quality of life and short term outcomes of children treated with intravenous magnesium during an acute pain crisis.
Detailed Description

It is well known that children with sickle cell disease are at risk for acute pain crises. The usual treatment for these pain crises, intravenous fluids and pain medicines such as morphine, has changed little over the past three decades. In a pilot study, the addition of intravenous magnesium to standard therapy decreased length of stay; however, this study was not randomized, not blinded, not placebo-controlled, and not adequately powered to assess safety.

We will conduct a multi-center, randomized, double-blind, placebo controlled trial of about 208 children, ages 4-21 years. Patients will be randomized to receive intravenous magnesium sulfate or placebo every 8 hours for a total of 6 doses, or until discharge. Patients will return for a routine clinic visit up to 3 months after discharge for a baseline assessment. Patients will also complete health-related quality of life measures at 4 timepoints throughout the study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE
  • Drug: Intravenous Magnesium Sulfate
    40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses
  • Drug: Normal Saline Placebo
    (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses
Study Arms  ICMJE
  • Experimental: Magnesium group
    Intravenous Magnesium Sulfate
    Intervention: Drug: Intravenous Magnesium Sulfate
  • Placebo Comparator: Placebo group
    Normal Saline placebo
    Intervention: Drug: Normal Saline Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2012)
208
Original Estimated Enrollment  ICMJE
 (submitted: September 8, 2010)
228
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age 4-21 years, inclusive
  • Sickle cell anemia (Hb SS) or Sickle beta zero thalassemia disease (Hb Sβ°)
  • failed intravenous opioid pain management in the emergency department prior to the decision to admit the patient
  • admitted to the inpatient unit for sickle cell pain crisis

Exclusion Criteria:

  • patient received more than 12 hours of intravenous pain medication prior to enrollment
  • previous enrollment in this study (only one admission per child is eligible)
  • history of allergy/intolerance to both intravenous morphine and hydromorphone
  • known other cause for pain (avascular necrosis, gall bladder disease, priapism, etc.)
  • patient with greater than 10 admissions for pain crisis in the past year
  • patient maintained on daily opioids or chronic transfusions for chronic sickle cell pain
  • transfusion within the previous two months
  • known kidney or liver failure (elevation of liver function tests does not warrant exclusion)
  • known pulmonary hypertension
  • pregnancy
  • diagnosis of bacterial infection, fever ≥39.5°C, acute chest syndrome, hemodynamic instability or sepsis
  • current oral magnesium supplementation or current enrollment in another therapeutic study protocol
  • previously diagnosed clinical stroke
  • current or planned use of neuromuscular blocker, nifedipine, ritodrine, or terbutaline
  • allergy to magnesium sulfate
  • discharge from an inpatient unit within 72 hours of arrival in the emergency department for the current pain crisis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01197417
Other Study ID Numbers  ICMJE PECARN 025
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical College of Wisconsin
Study Sponsor  ICMJE Medical College of Wisconsin
Collaborators  ICMJE Pediatric Emergency Care Applied Research Network
Investigators  ICMJE
Principal Investigator: David Brousseau, MD, MS Medical College of Wisconsin
PRS Account Medical College of Wisconsin
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP